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Clinical Trialsvirtual tour
HL7-IHE DemonstrationHIMSS 2004
Presented by
• Meredith Nahm– Director of Clinical Data Integration– Duke Clinical Research Institute
• Durham, North Carolina
Virtual Tour
• High-level animated walkthrough
• Detailed view– Application tools– Standards and Profiles
Clinical Trial
• Community Acquired Pneumonia Clinical Trial
• 250 Patients and 12 sites
• QT prolongation is a potential adverse event in the class of drugs under study
• Trial uses a Core Lab for Central reading of ECG’s
AdobeBerdyCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGEHeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS
Clinical Trials: Integrating with patient care
aECG ArdenCCOW
CDA CT
EUALDMODM
PIXPSARIDRIM
SDMSPL
SWFV2V3
Patients seen at PCP, hospitalsECGs sent to Core Lab; annotated on site or at Core Lab
Hospital
Hospital
Core Lab
Sponsor
FDA
PCP
Imaging
Central Lab
AdobeBerdy MedicalCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGE Medical SystemsHeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS
Clinical Trials: Integrating with patient care
Imaging aECG ArdenCCOW
CDA CT
EUAODM
PIXPSARIDRIM
SDMSPL
SWFV2V3
Sponsor identifies QT prolongationRequests additional documentation
Hospital
Hospital
Core Lab
Sponsor
FDA
Registry
PCP
Central Lab
Dictation Repository
Query broker, trusted 3rd party
AdobeBerdy MedicalCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGE Medical SystemsHeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS
Clinical Trials: Integrating with patient care
aECG ArdenCCOW
CDA CT
EUAODM
PIXPSARIDRIM
SDMSPL
SWFV2V3
Patients seen at PCP, hospitalsECGs sent to Core Lab; annotated on site or at Core Lab
AdobeBerdy MedicalCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGE Medical SystemsHeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS
Clinical Trials: Integrating with patient care
aECG ArdenCCOW
CDA CT
EUAODM
PIXPSARIDRIM
SDMSPL
SWFV2V3
Patients seen at PCP, hospitalsECGs sent to Core Lab; annotated on site or at Core Lab
AdobeBerdy MedicalCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGE Medical SystemsHeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS
Clinical Trials: Integrating with patient care
aECG ArdenCCOW
CDA CT
EUAODM
PIXPSARIDRIM
SDMSPL
SWFV2V3
Intervals for Analysis imported into Clinical Data Management System at Core Lab
AdobeBerdy MedicalCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGE Medical SystemsHeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS
Clinical Trials: Integrating with patient care
aECG ArdenCCOW
CDA CT
EUAODM
PIXPSARIDRIM
SDMSPL
SWFV2V3
Analysis data in ODM/SDM delivered to SponsorSponsor uses FDA Viewer to view waveforms
AdobeBerdy MedicalCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGE Medical SystemsHeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS
Clinical Trials: Integrating with patient care
aECG ArdenCCOW
CDA CT
EUAODM
PIXPSARIDRIM
SDMSPL
SWFV2V3
Sponsor identifies QT prolongationPolls registry through a Third Party Broker
AdobeBerdy MedicalCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGE Medical SystemsHeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS
Clinical Trials: Integrating with patient care
aECG ArdenCCOW
CDA CT
EUAODM
PIXPSARIDRIM
SDMSPL
SWFV2V3
Sponsor requests additional informationQueries NIST registry, and obtains documents through a Third Party broker
AdobeBerdy MedicalCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGE Medical SystemsHeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS
Clinical Trials: Integrating with patient care
Sponsor submits SDM data to the FDAUsing HL7 v3 message and CDISC/HL7 standards
aECG ArdenCCOW
CDA CT
EUAODM
PIXPSARIDRIM
SDMSPL
SWFV2V3
AdobeBerdy MedicalCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGE Medical SystemsHeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS
Clinical Trials: Integrating with patient care
FDA uses Patient Profile Viewer and ECG ViewerTo view SDM and waveform data
aECG ArdenCCOW
CDA CT
EUAODM
PIXPSARIDRIM
SDMSPL
SWFV2V3
AdobeBerdy MedicalCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGE Medical SystemsHeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS
Clinical Trials: Integrating with patient care
Imaging aECG ArdenCCOW
CDA CT
EUAODM
PIXPSARIDRIM
SDMSPL
SWFV2V3
Patients seen at PCP, hospitalsECGs sent to Core Lab, Sponsor and FDA
Hospital
Hospital
Core Lab
Sponsor
FDA
Registry
Query broker, trusted 3rd party
Repository
PCP
Central Lab
Dictation Repository
AdobeBerdyCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGE HeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS
HL7 aECG ArdenCCOW
CDA ODMLDMRIM
SDMSPLV2V3
IHECT
EUAPIX
PSARID
SWF
Special thanks to• Mallinckrodt Institute of Radiology
– Patient Identifier Cross Referencing (PIX) server• Fred Behlen, Laitek Technologies
– DICOM SR to CDA transformation• The SIMI Group
– State Department of Health application• Michael Palmer, Zurich Biotech
– SAS to ODM conversion• NorthEast Monitoring
– Corelab software integrating aECGs• CSS Informatics
– FDA Patient Profile Viewer• AMPS
– FDA aECG Viewer• Amnon Shabo, IBM Haifa
– Sample CDA Botulism Case Report• Data Conversion Labs
– Sample Structured Product Labeling transformation
AdobeBerdyCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGE HeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS
HL7 aECG ArdenCCOW
CDA ODMLDMRIM
SDMSPLV2V3
IHECT
EUAPIX
PSARID
SWF
Demo Executive Committee
• HL7– Karen Van Hentenryck, HL7
Associate Director– Landen Bain, Co-chair, HL7
Marketing Committee
• IHE– Joyce Sensmeier, HIMSS– Chris Carr, RSNA
AdobeBerdyCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGE HeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS
HL7 aECG ArdenCCOW
CDA ODMLDMRIM
SDMSPLV2V3
IHECT
EUAPIX
PSARID
SWF
Invitation to Tour
• Guided Tours start on the quarter hour• Self-guided Tours anytime
– Maps available at Reception
• Complete a tour, win a prize– Get each location initialled by participant– Go to reception with completed map– Enter a business card to win
• HL7 Working Group Registration (drawing 1/day)
• HIMSS 2005 Registration (drawing 1/week)
GE
RA600
Guided tours on the quarter hour; Self-guided tours any time
Take A Tour, Win A Prize!•Get a stamp at every stop on a tour•Take stamped Tour Guide to receptionist•Enter to win a Prize! -HL7 Registration or -HIMSS 2005 Registration
Continuity of Care Tour
Clinical Trials Tour
Patient Safety Tour
Public Health Tour
aECG Annotated ECG (V3) 4, 16, 19, 20,21, 27
Arden Arden Syntax Medical Logic Modules 17, 19, 26
CCOW Clinical Context Object Workgroup 1,14, 15, 17, 18, 28, 29, 30
CDA Clinical Document Architecture (RIM) 2, 6, 7, 9, 10, 11, 12, 13, 20, 22, 23, 24, 25, 26, 32
CT Integration Profile for Consistent Time 1, 2, 18, 30
EUA Enterprise User Authentication (Kerberos) 1, 2, 14, 18, 28, 30
Integration Profiles: 1, 2, 3, 6, 8, 10, 11, 14, 15, 18, 28, 29, 30, 31
LDM Lab Data Model (V3, CDISC) 20
ODM Operational Data Model (CDISC) 20, 21
PIX Patient Identifier Cross Referencing (V2) 1, 11
PSA Patient Synchronized Application (CCOW) 1, 14, 18,28, 29, 30,
RID Retrieve Information for Display 1,8, 10,11,15,18,29, 30
RIM Reference Information Model (V3) 2, 4,6, 7, 9, 10, 11, 12, 13, 16,19,20,21, 22, 23, 24, 25, 26, 27,32
SDS Submissions Data Standard (CDISC) 20, 21
SPL Structured Product Label (CDA) 19
SWF Scheduled Work Flow (V2, DICOM) 1,2,3,29,31
V2 Version 2 messaging 1,5,6, 8, 9,11,12,17,18,22,25,26,32
V3 Version 3 messaging 4,9,10,11,16,19,20,21,22,24,27,32
Start
Start
Start
GE CW
eb
Kodak
GE Solar
Carefx/G
E
Mortara
GE ED
Eclipsy
s
Digita
lInfu
zion
DCRI
CDC/
UCDavisPhilip
s
Adobe
Epic
GE CPortal
Sentillio
n
INFIN
ITTXim
is
Kryptiq
CommerceNet
MS InfoPath
GE MUSE ACP/F
DA
NIST
Start
Berdy
MS BTS
Raining Data
Dictaphone
Soarian
SNOMED
Siemens O
L
1 2
3
T H E A T E R
C L
A S
S R
O O
M
Misys
4
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913
1012
11
23 24 25 26 27
2829303132
21
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14 15
18 17
1619
20
AIS
LE
AISLE
Tour Guide
HL7-IHE Interoperability Demonstration
Booth 4638
Walking Tour
AdobeBerdyCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGE HeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS
HL7 aECG ArdenCCOW
CDA ODMLDMRIM
SDMSPLV2V3
IHECT
EUAPIX
PSARID
SWF
Thank you
• Questions?
• Tours starting now
• This presentation will be available on www.rsna.org/IHE/hl7ihedemo